The PErineal Assessment and Repair Longitudinal Study (PEARLS): a national quality improvement initiative to improve the assessment and immediate, short and long term management of perineal trauma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28960026

Enrollment

1000

Registered

2008-03-26

Start date

2005-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal trauma Pregnancy and Childbirth Perineal trauma

Interventions

A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal t

Fax: +44 (0)1782 552472

Email: Linda.Lucking@uhns.nhs.uk Sue Tohill: Tel: +44 (0)7880 942330

Email: sue.tohill@rcm-pearls.org

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses.

Exclusion criteria

Exclusion criteria: 1. Women under 16 years of age 2. Non-English speakers 3. Those who have suffered pregnancy loss

Design outcomes

Primary

Measure	Time frame
21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows: Experience of perineal pain on daily activity at 10-12 days post birth. Previous primary outcome measures until 21/03/2013: Women's perspectives on what they consider important in the quality and experience of their care: 1. Infection and antibiotic treatment 2. Pain 3. Healing 4. Continence	—

Measure

Time frame

21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows: Experience of perineal pain on daily activity at 10-12 days post birth. Previous primary outcome measures until 21/03/2013: Women's perspectives on what they consider important in the quality and experience of their care: 1. Infection and antibiotic treatment 2. Pain 3. Healing 4. Continence

—

Secondary

Measure	Time frame
21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows: 1. 10 - 12 days post birth: 1.1. severity of perineal pain 1.2. need for suture removal 1.3. use of pain relief duirng the previous 24 hours 1.4. uptake and duration of exclusive breastfeeding 1.5. perineal wound infection 2. Three months post birth: 2.1. Edinburgh Postnatal Depression Scale (EPDS [14]) score of = 13 2.2 timing of resumption of intercourse 2.3. satisfaction with the perineal repair. 2.4. duration of exclusive breastfeeding Previous secondary outcome measures until 21/03/2013: 1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires: 1.1. Incidence of perineal pain 1.2. Use of postpartum analgesia 1.3. Perineal wound infection 1.4. Uptake and duration of breastfeeding 2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.	—

Measure

Time frame

21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows: 1. 10 - 12 days post birth: 1.1. severity of perineal pain 1.2. need for suture removal 1.3. use of pain relief duirng the previous 24 hours 1.4. uptake and duration of exclusive breastfeeding 1.5. perineal wound infection 2. Three months post birth: 2.1. Edinburgh Postnatal Depression Scale (EPDS [14]) score of = 13 2.2 timing of resumption of intercourse 2.3. satisfaction with the perineal repair. 2.4. duration of exclusive breastfeeding Previous secondary outcome measures until 21/03/2013: 1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires: 1.1. Incidence of perineal pain 1.2. Use of postpartum analgesia 1.3. Perineal wound infection 1.4. Uptake and duration of breastfeeding 2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026